SOP applies to all new gel products developed and manufactured in the Gel Manufacturing Department. It includes preparation, review, approval, and issuance of BMRs.

3. Responsibilities

• Formulation Development Team: Provide initial formulation and processing details.
• Production Personnel: Draft the BMR based on development data and production capacity.
• Quality Assurance: Review, approve, and control issuance of BMRs.

4. Accountability

The Manufacturing Head is accountable for implementing this SOP. The Quality Assurance Head is responsible for ensuring adherence to documentation standards and regulatory compliance.

5. Procedure

5.1 Initiation of BMR

1. Upon finalization of a gel formulation from the R&D team, initiate BMR preparation.
2. Obtain all relevant documents: formulation sheet, manufacturing flow chart, equipment list, and stability data.

5.2 Drafting the BMR

1. Create BMR using the master BMR template – Form No. GM/BMR/F01.
2. Include product name, product code, generic name, dosage form, strength, and batch size.
3. Add detailed manufacturing steps with exact quantities and sequence of raw material addition.
4. Specify equipment used, operating parameters (e.g., mixing speed, time, temperature), and hold times.
5. Insert in-process tests (e.g., pH, viscosity, homogenization efficiency) at appropriate stages.

5.3 Key Sections of the BMR

• Bill of Materials
• Dispensing Instructions
• Manufacturing Instructions
• Filling and Packing Instructions
• In-Process Control Tests
• Yield Calculations
• Deviation Record (if any)
• Reconciliation of Raw Materials and Packaging
• Final Yield Statement
• Signatures for each activity

5.4 Review and Approval

1. Send the drafted BMR to QA for review of technical correctness and compliance with cGMP.
2. QA shall verify critical process parameters, in-process checks, and quality data.
3. Once approved, assign a unique BMR number and log it in the BMR master register.

5.5 Issuance

1. QA to print controlled copies on pre-numbered paper with watermarked “Controlled Copy.”
2. Issue to the Production department along with raw material requisition slip and packaging specs.

5.6 Post-Manufacturing Steps

• Production to fill all fields in real-time using black ink with legible handwriting.
• Any correction must be struck through with a single line and signed with date and initials.
• On completion, return the BMR to QA for archival and future reference.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• cGMP: current Good Manufacturing Practices
• R&D: Research and Development

7. Documents

1. Master BMR Template – Annexure-1
2. Sample Filled BMR – Annexure-2
3. BMR Review Checklist – Annexure-3
4. BMR Number Log Sheet – Annexure-4

8. References

• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
• Schedule M – Good Manufacturing Practices
• ICH Q10: Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Master BMR Template

Template file code: GM/BMR/F01 – Includes all standard sections and formatting guidelines.

Annexure-2: Sample Filled BMR

Sample BMR for batch GM-GEL-001 showing complete entries for a 100 kg gel batch with process validations.

Annexure-3: BMR Review Checklist

• Are all stages of manufacturing clearly defined?
• Are IPC checks included with limits?
• Does the BMR comply with the Master Formula?

Annexure-4: BMR Number Log Sheet

BMR No.	Product Name	Date Issued	Issued By
BMR/GM/001	Gel A	01/05/2025	QA Executive
BMR/GM/002	Gel B	10/05/2025	QA Executive

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial release	New product development	QA Head
02/06/2025	2.0	Annexures added and structure aligned with Schedule M	Annual revision	QA Head